I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-SKIN ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NOVA LITE ENDOMYSIAL

FDA 510(k)

FDA Class 2 ·Immunology

ANTINUCLEAR ANTIBODY SCREEN FLOURESC

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER

FDA 510(k)

FDA Class 2 ·Immunology

ANTI-ENDOMYSIAL ANTIBODY TEST

FDA 510(k)

FDA Class 2 ·Immunology

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PUREtrace™

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor

FDA 510(k)

FDA Class 2 ·Radiology

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MILLS COLUMELLA PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DILKES LASER/SUCTION CANNULAE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGH SPEECH SYSTEM (SERIES 'SSS')

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BEL-AIR VENTILATION TUBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MYOTRAC INFINITI ELECTRICAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat